SATO CLEAR- naphazoline hydrochloride solution/ drops 
Sato Pharmaceutical Co., Ltd.

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Sato Clear

Active ingredient
Naphazoline hydrochloride 0.012%

Purpose
Naphazoline hydrochloride      Vasoconstrictor

Uses relieves this symptom due to minor eye irritations
■ redness of the eye

Warnings

For external use only

Do not use

  • if solution changes color or becomes cloudy

Ask a doctor before use if you have

  • narrow angle glaucoma

When using this product

  • pupils may become enlarged temporarily
  • overuse of this product may produce increased redness of the eyes
  • to avoid contamination, do not touch tip of container to any surface
  • replace cap after using

Stop use and ask a doctor if you experience

  • eye pain
  • changes in vision
  • continued redness or irritation of the eye
  • the condition worsens or persists for more than 72 hours

Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.

Directions
■ Place 1 or 2 drops in the affected eyes up to 4 times daily.

Other information

Inactive ingredients benzalkonium chloride, boric acid, dl-camphor, sodium borate, sodium chloride, purified water.

Carton

SATO CLEAR 
naphazoline hydrochloride solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49873-044
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HYDROCHLORIDE12 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
BORIC ACID (UNII: R57ZHV85D4)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49873-044-011 in 1 CARTON05/31/1989
115 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01805/31/1989
Labeler - Sato Pharmaceutical Co., Ltd. (690575642)
Establishment
NameAddressID/FEIBusiness Operations
Sato Pharmaceutical Co., Ltd.715699133manufacture(49873-044) , label(49873-044) , pack(49873-044)

Revised: 11/2023
Document Id: 0b401747-48ee-3b1d-e063-6394a90aeebd
Set id: e0317a10-7b94-41c8-8d2b-0e3b6fc4ef60
Version: 7
Effective Time: 20231128
 
Sato Pharmaceutical Co., Ltd.